Committed supply of high-quality controlled substances from a trusted 503B outsourcing facility
From pre-filled, ready-to-use, operating room syringes to intravenous (IV) bags, Fagron Sterile Services US (FSS) state-of-the-art facilities are prepared to handle the production of sophisticated sterile medications.
Safety. Quality. Control. No Compromise.
Customer is #1
We always deliver excellent customer service! Our expertise, dedication and passion serve to improve the quality of life of patients around the world.
Speed of execution
We act with urgency, work smart and have the courage to change course when needed.
Entrepreneurship
We take ownership, possess an entrepreneurial spirit and challenge our peers.
Creativity
We are problem solvers, relentlessly pursuing innovation and continuous improvement.
Quality
We aim to deliver excellence — nothing less will do. Quality is our center, ingrained in our work, culture and vision.
Fagron Lab
Our global product line of compounding equipment specially designed and developed by Fagron, for the needs of modern compounding pharmacies.
Compounding
A globally trusted compounding expert with over three decades of experience, pharmaceutical compounding represents the origin and cornerstone of Fagron.
Fagron Tech
Our healthcare and business development solution for the pharmacy and beyond — offering integrated operational, administrative, financial management systems and more.
Fagron Genomics
Our laboratory services company, focused on providing specific pharmacogenetics and diagnostic molecular analysis for healthcare professionals.
Quality you can rely on
FSS employs decades of sterile pharmaceutical manufacturing and quality expertise. Customers appreciate our trusted supplier management, product development, process validation, environmental monitoring, state-of-the-art production, advanced product testing, and safeguarded customer ordering and shipping from secure facilities.
Experience top-tier 503B outsourcing firsthand . Request a free consultation at the bottom of this page and set up a virtual or in-person site audit (COVID restriction may apply).
FDA / DEA Registered & Inspected
Compliance with FDA, DEA, cGMP, GDP and cGLP regulations and guidance ensure our process is sound and supports patient safety
cGMP Compliant
Three decades of experience employing subject matter expertise with 21 CFR Parts 210 and 211 produces quality you can trust
ISO 5 environments
16 independent aseptic processing environments with dedicated HVAC systems, automation and depyrogenation technology
Committed Supply
The medication you want, when you need it — period. Committed Supply Program customers enjoy greater than 97% same-day fill rate on orders placed before cut-off times
100%Tested
All batches must successfully pass tests for sterility, particulate matter and potency prior to being released
Advanced labeling with drug schedule indication
Thoughtful OR syringe and IV bag labeling supports patient safety on every controlled substance product from FSS. Advanced labeling allows clinicians to quickly identify the most critical presentation information, including the drug schedule and safety warnings.
Controlled substance labels clearly display:
- Presentation specification
- Route of administration
- Storage requirements
- Expiration dating
- TALLman lettering
- Drug schedule
- Barcode
Drug Scheduling
The United States Drug Enforcement Agency (DEA) classifies drugs and chemicals used to manufacture drugs into five unique categories or schedules based upon a drug’s medical use and potential for abuse or dependency.
Fagron Sterile Services US currently provides customers with a reliable supply of Schedule II, III, and IV controlled substances.
Secure Storage
With controlled substances, security is critically important. In our 503B outsourcing facility, controlls are protected by a state-of-the-art security system with 24-hour monitoring.
Drugs are stored in a massive concrete and steel vault under detailed activity tracking by dozens of security devices throughout the facility. This helps support the safety of our employees and your patients.
Employee interactions with controlled drugs are limited to a select group who have received advanced training and undergone specific background screenings.
Streamlined Ordering
Convenient CSOS electronic ordering provides FSS customers with the ease of digitally signing for Schedule II medications and placing full orders without ever having to leave the FSS web shop.
Why CSOS electronic ordering?
Together we create the future of personalizing medicine.
Over the past 34 years, Fagron has earned the trust of pharmacists in communities across more than 30 countries by prioritizing transparency and delivering high-quality medications supporting patient care.
Fagron Sterile Services US (FSS) is a DEA and FDA-registered and inspected supplier, providing a broad portfolio of high-quality sterile medication and expertise in pharmaceutical manufacturing, repackaging, patient safety, regulatory guidance and pharmacy.
234,000 ft²
Capacity across 3 state-of-the art operational facilities
100%
of batches tested for sterility, particulate matter and potency to support patient safety
Diverse product portfolio
Supporting providers and the patients you serve across the continuum of care
Instant ship program
Medications when you need them the most, in-stock, ready to ship
Talk with your personal representative
FSS demonstrates a commitment to patient safety through high-quality 503B outsourcing and partnering with customers to provide a reliable supply of controlled substance medications to support patient care.
Globally and vertically integrated operations
Fagron’s 4k+ employees serve 30+ countries from 70+ facilities
Proactively supporting supply chain resiliency
Fagron’s global team of 100 supply chain experts leverage 3k+ suppliers
Diverse portfolio across the continuum of care
FSS supports patient care from the delivery room to the O.R.
including clinics